Overview
A rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I (cTnI) in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).
Intended Use
Intended as an aid in the diagnosis of myocardial infarction (MI) by detecting cardiac Troponin I (cTnI); reactive specimens should be confirmed by alternative methods together with clinical findings.
Directions for Use
1. Allow the test, specimen and buffer to reach room temperature (15-30µC), then remove the cassette from its pouch and place it on a clean, level surface.
For serum or plasma: add 2 drops (approx. 50 µL) to the specimen well, then add 1 drop of buffer (approx. 40 µL) and start the timer.
For venipuncture whole blood: add 3 drops (approx. 75 µL) to the specimen well, then add 1 drop of buffer (approx. 40 µL) and start the timer.
For fingerstick whole blood: transfer approx. 75 µL (via capillary tube or 3 hanging drops) to the specimen well, then add 1 drop of buffer (approx. 40 µL) and start the timer.
Read the result at 10 minutes; do not interpret after 20 minutes.
Reading the Result
- Positive – two lines appear: one at the control region (C) and one at the test region (T). Any shade of colour at the test region is positive.
- Negative – one colored line appears at the control region (C); no line at the test region (T).
- Invalid – the control line fails to appear; review the procedure and repeat with a new test.






